Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 the patient underwent for a degenerative surgery.During the surgery, both of the screwdrivers shaft was disengaged with the screw.The surgery was completed without any other issue.The patient outcome was unknown.This complaint involves five (5) devices.This report is for (1) verse poly driver, handle.This report is 3 of 5 for (b)(4).
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Product complaint #(b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: d9: device received.D11: additional concomitant device reported.Investigation summary background shaft for screwdriver disengage meaning screw was not fixed well with both screwdriver so he used another one and the case went well with no issues source: national guard.Surgery: degenerative.This complaint involves five (5) devices.Investigation flow: device interaction/functional.Visual inspection: visual inspection performed at customer quality (cq) showed no issues to the instrument, no signs of damage.A device failure was not identified.Functional test functional test was performed with the returned screwdriver and no issues were observed; additionally the handle does not interact directly with the screw.Dimensional inspection: a dimensional inspection was performed as no issues were noted on the instrument.Document/specification review: the following drawings were reviewed: expedium verse poly driver driver body: dwg-887031417 rev c/b.Based on the review of the above drawings, no design issues contributing to relevant complaint condition were identified.Conclusion: no definitive root cause was able to be determined as the complaint is unconfirmed.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: a review of the receiving inspection (ri) for verse poly driver, handle was conducted identifying that lot number pu128668 was released in two batches.Batch1: lot qty of (b)(4) units were released on 18 jul 2018 with no discrepancies.Batch2: lot qty of (b)(4) units were released on 26 jul 2018 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Device history batch null, device history review the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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